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EnterpriseOne Consulting Announces Training to Work in thePharmaceutical...



The Department of Health and Human Services has been expanding their Pandemic Flu emergency preparedness program and has funded several major pharmaceutical companies to develop a cell based H5N1 bird flu vaccine to be produced at 4 US based plants. In 2011 these plants will be expected to be in full operation and therefore the need for FDA regulations trained Manufacturing, engineering, Information technology and laboratory personnel to handle daily business operations.



If you would like to learn the requirements to work in the pharmaceutical industry then the EnterpriseOne training program will provide the following essential programs.



1.    Fundamentals of current Good Manufacturing Practices


2.    Writing, and following Standard Operating Procedures


3.    Good Documentation Practices


4.    Validation


a.    Data Center, hardware and software Qualification Protocols and Testing to meet FDA 21 CFR part 11 regulations.


b.    Equipment Commissioning, OQ,PQ testing and lifecycle documentation


c.    Process Validation Methods


d.    Cleaning Validation


e.    Packaging Validation



This training program will be developed over the next two months and is a solid path to success for those from outside the pharmaceutical industry who wish to start a new career path. Who should attend


>    Manufacturing and Packaging Operations staff, from chemical and other high volume manufacturing environments.


>    Facility, Maintenance and Engineering Staff


>    Scientific and laboratory personnel.






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